Drug Evaluation Committee ICH E19 "Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted after Approval or Post-approval in the Late Phase of Development" Key Considerations for Conducting Studies - Mainly from the Perspective of Data Management
Data Science Subcommittee
November 2024
The ICH E19 guideline is intended to streamline the collection of safety data for specific clinical trials conducted in late-stage development or post-approval to enable efficient trial management. This approach is expected to enable more efficient collection of safety data and smooth operation of clinical trials. However, confusion when dealing with unusual operational practices can reduce efficiency and may prevent the objectives of the guidelines from being achieved. Therefore, proper preparation is critical.
This document understands the intent of the E19 guidelines, devises the necessary processes for each phase of a clinical trial involving data management, and provides a specific operational guide for studies applying Selective Safety Data Collection (SSDC) The application of SSDC will ensure efficient clinical trial operations and help the reader to The goal is to help you prepare for the application of SSDC in a way that avoids confusion. We hope that this document will be of assistance to you in your work.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee 2024 Ongoing Task Force 9
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